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The Link Between BRCA Mutation and Endothelial Function

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ClinicalTrials.gov Identifier: NCT02474264
Recruitment Status : Unknown
Verified October 2016 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : June 17, 2015
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE February 23, 2015
First Posted Date  ICMJE June 17, 2015
Last Update Posted Date July 18, 2017
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2015)
reactive hyperemia index will be assessed using the Endo-PAT2000 [ Time Frame: at baseline ]
will be assessed using the Endo-PAT2000
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2016)
  • The level of high sensitivity troponin (hsTn) - a cardiovascular risk biomarker will be measured [ Time Frame: at baseline ]
    high sensitivity troponin (hsTn)
  • The level of C-reactive protein - a cardiovascular risk biomarker will be measured [ Time Frame: at baseline ]
    C-reactive protein
  • The level of D-dimer - a cardiovascular risk biomarker will be measured [ Time Frame: at baseline ]
    D-dimer
  • The level of N-terminal pro-brain natriuretic peptide (NT-proBNP) - a cardiovascular risk biomarker will be measured [ Time Frame: at baseline ]
    N-terminal pro-brain natriuretic peptide (NT-proBNP)
  • Endothelial Progenitor Cells profile (EPC) - will be characterized to evaluate endothelial injury. [ Time Frame: at baseline ]
    Endothelial Progenitor Cells (EPC)
  • Circulating Endothelial Cells profile (CEC) - will be characterized to evaluate endothelial injury. [ Time Frame: at baseline ]
    Circulating Endothelial Cells (CEC)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2015)
  • The level of high sensitivity troponin (hsTn) - a cardiovascular risk biomarker will be measured [ Time Frame: at baseline ]
    high sensitivity troponin (hsTn)
  • The level of C-reactive protein - a cardiovascular risk biomarker will be measured [ Time Frame: at baseline ]
    C-reactive protein
  • The level of D-dimer - a cardiovascular risk biomarker will be measured [ Time Frame: at baseline ]
    D-dimer
  • The level of N-terminal pro-brain natriuretic peptide (NT-proBNP) - a cardiovascular risk biomarker will be measured [ Time Frame: at baseline ]
    N-terminal pro-brain natriuretic peptide (NT-proBNP)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Link Between BRCA Mutation and Endothelial Function
Official Title  ICMJE The Link Between BRCA Mutation and Endothelial Function - A Pilot Study
Brief Summary This study evaluates the effect of BRCA1&2 mutations on cardiovascular diseases by to comparing the endothelial function of male BRCA mutation carriers with that of age matched non-BRCA mutation carriers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • BRCA1 Gene Mutation
  • BRCA2 Gene Mutation
Intervention  ICMJE
  • Other: Endothelial function assessment
    reactive hyperemia index
  • Other: Cardiovascular biomarkers
    Cardiovascular biomarkers will be measure to test other aspects of endothelial and cardiac function: high-sensitivity troponin (hsTn) , C-reactive protein , D-dimer, N-terminal pro-brain natriuretic peptide (NT-proBNP)
  • Other: Endothelial cells
    Endothelial Progenitor Cells and Circulating Endothelial Cells profiles- will be characterized to evaluate endothelial injury.
Study Arms  ICMJE
  • male BRCA mutations carriers
    Endothelial function assessment and Cardiovascular biomarkers
    Interventions:
    • Other: Endothelial function assessment
    • Other: Cardiovascular biomarkers
    • Other: Endothelial cells
  • healthy males - control group
    Endothelial function assessment and Cardiovascular biomarkers
    Interventions:
    • Other: Endothelial function assessment
    • Other: Cardiovascular biomarkers
    • Other: Endothelial cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 12, 2015)
82
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Known carrier or non-carrier, confirmed by genetic testing of BRCA 1/2 mutation
  • Able and willing to sign an informed consent

Exclusion Criteria:

  • History of, or current, malignancy
  • History of:

    • Myocardial infarction
    • Ischemic or Hemorrhagic cerebrovascular conditions
    • Arterial embolic and thrombotic events
    • Ischemic heart disease
    • Prior coronary artery or ilio-femoral artery revascularization (percutaneous or surgical procedures)
    • Peripheral vascular disease (e.g. claudication, prior vascular surgery/intervention)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02474264
Other Study ID Numbers  ICMJE 0594-14-RMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Margel, MD, PhD Rabn Medical Center, Beilinson Campus
PRS Account Rabin Medical Center
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP